MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion

Regulatory LabelingAnalyst

Collaborate closely with key interfaces on projectrequirements to ensure timelines are mutually understood.

• Drafting responses to MAH for Health Authority queries.

• Identify discrepancies/issues in local implementationof corporate labels.

• Lead team for timely results.

• Supervise reference labels (from up to three countries)for updates and ability to connect with concerned affiliates directly usingcommunication/collaboration tools.

• Maintaining updates related to labeling guidelines andregulations as they pertain to the development/maintenance of IFU, CCDS, US, EUand ROW labeling (Pharma/Device).

• Ability to identify discrepancies/issues in localimplementation of corporate labels and contact the affiliates (if appropriate)for remediation actions

• Construct a Company Response (MAH response) for healthauthority questions Minimum Qualifications

MakroCare | AMakroGroup Company | www.MakroCare.com

MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion.

MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)

MakroCare Awardedas:

•             BestBiopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma

•             BestPharmaceutical Strategic Development Specialist - UK Enterprises

•             TheOutstanding Consulting Firm - Insights Success

•             AIExcellence in Regulatory & Automation Solutions - Acquisition International

•             AIExcellence in Best Bio Pharma Development Partner - Acquisition International

•             BestPractices Award - Clinical Informatics

•             NJExcellence Award - US Institute for Excellence in Commerce

•             BestBiotech Award - US Commerce Association

•            Clinical Research Team and Best Technological Development in ClinicalTrials Finalists - Scrip Awards

•            Circle Of Excellence – MerchantCircle

About MakroGroup |www.MakroGrp.com

Makro Group of Organizations established in 1996, Makroprovides a complete range of solutions for every stage of business andinformation lifecycle.

•            MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies

•             DDiAwarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook,Clinical Informatics & SCRIP

•            MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company& TOP 100 diversity business in NJ

•            MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSRInitiative, has counseled over 3000 people.